fda

RECENT POSTS

February 10, 2015 | 8:11 AM | Jean Fain

For more than 20 years, my binge-eating patients have wished for a magic wand. And for all that time I told them there is no wand — there are only strategies that require awareness and effort to get a handle on their eating.

Last week, when the FDA announced it had approved Vyvanse for the treatment of binge eating disorder (BED), I found myself at an uncharacteristic loss for words. With headlines touting a magical cure for this most common adult eating disorder, I feared there was nothing I could say to stop the stampede for this next, new drug.

The news, in and of itself, is hopeful. Vyvanse (lisdexamfetamine dimesylate) has been the subject of rigorous research, first for ADHD, and now for BED. In two good-sized studies with more than 700 adult participants diagnosed with moderate to severe binge eating, this central nervous system stimulant proved more effective at reducing binge days per week than placebo for three months.

What’s more, the FDA’s approval has proven a good opportunity for a drugmaker, U.S-based Shire, and leading eating disorder associations — the National Eating Disorder Association and Binge Eating Disorder Association — to coordinate a nationwide educational campaign. If even a fraction of the estimated 2.8 million Americans diagnosed with the disorder get help as a result of the campaign’s public service announcements and new website, there’s reason to be hopeful.

There’s also reason to be cautious. Consider some of the issues before you take tennis great and Shire spokesperson Monica Seles’ advice to “talk with your doctor.” To help you do that, here are the pros and cons in my clinical experience and that of my colleagues.

But first, if you’re unclear on what constitutes binge eating disorder, here’s how the Binge Eating Disorder Association defines it:

“Routinely eating far more food than most adults would in a similar time period under similar circumstances.” Binge eaters typically feel out of control during a binge, and afterward, they’re consumed with guilt, self-disgust and embarrassment. Other hallmarks of the disorder: eating extremely fast, in secret, to the point of uncomfortable fullness, even when not hungry. Unlike other eating disorders, people with BED don’t try to “undo” excessive eating by throwing up, taking laxatives and other excessive actions.

OK, so here are a few points to consider…

Pros:

•More Treatment Options

With the FDA’s first and only approved medication for BED, patients now have another way into treatment: their family doctor. Rather than seeking out a psychotherapist or a nutritionist, which many are reluctant to do, they might feel more comfortable asking their physician about a prescription and other treatment options for this lesser-known eating disorder, which was only recognized two years ago as a distinct disorder by the American Psychiatric Association.

•Fewer Binge Days

Vyvanse has been shown to markedly reduce, if not eliminate, binge episodes in two studies, both funded by Shire. According to last month’s JAMA Psychiatry study, participants who got a daily dose of 50-70 mg, reduced the frequency of binge days per week from about five to less than one over the course of 12 weeks. By comparison, those taking placebo continued to binge more than two days per week. What’s more, half the participants taking the 70 mg dose stopped binging after four weeks, compared to one fifth of those taking placebo.

•Possible Weight Loss

Because Vyvanse has yet to be studied as a weight loss aid, it’s approved only in the treatment of binge eaters, not the overweight or the obese. That said, study subjects who took Vyvanse lost about 10 pounds. The potential weight loss may come as welcome news to bingers taking an off-label prescription for an antidepressant or anti-seizure medication. A common side effect of most antidepressants is weight gain. While binge eaters are often thrilled with the weight loss that the anti-seizure drug Topomax can facilitate, they’re none too pleased by the mental impairment.

Cons:

•Greater Risk of Abuse/Dependency

There’s a reason Vyvanse is a controlled substance with a black box warning. The potential for abuse and dependence is a real risk. Take it from psychiatrist Daniel Carlat, editor in chief of The Carlat Psychiatry Report, who expressed his reservations in a recent email exchange:

December 9, 2014 | 5:41 PM | Dr. Adam Urato

Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.

For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.

This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.

So what exactly does all this mean for consumers?

As a Maternal-Fetal Medicine specialist, here’s my read on the changes:

What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.

And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.

Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading →

May 27, 2014 | 11:59 AM | Rekha Murthy

Update: KV Pharmaceutical changed its name to Lumara Health, two days after this post was published.

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.

Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.

Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to…wait for it…$833 per dose, according to the new pharmacy my insurer is now requiring me to use.

$833. Per. Dose.

Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.

The 12-fold leap in my co-pay sent an epic shock through my (natural and synthetic) hormone-laden system. I immediately called both pharmacies, my insurer, and my doctor, and started digging around online. I soon learned that the price increase came from a new requirement to buy expensive brand-name progesterone, instead of the affordable compounded version I had been getting. A disturbing picture came into focus. Continue reading →

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading →

Intuitive Surgical Inc. (ISRG), the maker of a $1.5 million robot surgery system, told doctors that friction in the arms of some devices may cause the units to stall, the second warning issued about the company’s products in a month.

The company sent an “urgent medical device recall” Nov. 11 alerting customers of the issue, which affects 1,386 of the systems worldwide, the U.S. Food and Drug Administration said in a Dec. 3 notice on its website. The stalling may result in a sudden “catch-up” if the surgeon pushes through the resistance, the agency said.

Intuitive is facing growing questions about its marketing strategies, training procedures and the safety of its devices, Bloomberg News has reported. The FDA said last month that the number of adverse event reports, including deaths, injuries and system malfunctions, has more than doubled this year as of Nov. 3 compared with all of 2012.

“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA said on its website. Continue reading →

A rock of actual crystal meth (not the analog found in Craze.) Photo: Psychonaut/Wikimedia Commons

In medical research, “impact” usually refers to the number of times that an article or a journal is cited by others going forward. If your findings only ever find their way into, say, three sets of footnotes in other people’s papers, you can be pretty sure your impact is minimal.

In journalism, however, when you’re, say, applying for a Pulitzer prize, you need to show “impact” in the sense that your stories have led to significant change: The corrupt sheriff was ousted, or the systemic injustice corrected.

Dr. Pieter Cohen (Courtesy Cambridge Health Alliance)

Dr. Pieter Cohen, a general internist at Cambridge Health Alliance who researches dietary supplements, has just crossed the line from the academic sort of impact to the journalistic: On Monday, he and colleagues published a paper warning that they had analyzed the popular pre-workout supplement Craze and found that it contained a little-studied methamphetamine-like substance. Now, USA Today reports: “Driven Sports, maker of the pre-workout supplement Craze, announced Tuesday that it has suspended all production and sales of the product in the wake of tests finding amphetamine-like ingredients.”

In fact, Driven Sports writes on its Website that it stopped production “several months ago while it investigated the reports in the media regarding the safety of Craze” — though it also maintains that Craze is safe and its own testing has found no amphetamine or other controlled substances.

But would we have known that Craze production had been suspended if Dr. Cohen’s study in the journal Drug Testing And Analysis had not appeared? We asked him for his main messages from the Craze tale, and he replied:

• Supplements are all assumed safe until proven otherwise by the FDA. But the FDA has no effective system to detect hazardous supplements.

• In this setting it’s concerning to find that more and more supplements, like Craze, that contain new, untested compounds. This can lead to serious health effects: The FDA is currently investigating whether a new ingredient in a weight loss supplement, aegeline, was responsible for one death and dozens of cases of severe hepatitis in Hawaii. Continue reading →

FDA Commissioner Margaret A. Hamburg and colleagues visited research facilities and rice farms in California on Sept. 4-5, 2013 in an effort to gain a greater understanding of the presence of arsenic in rice.Photo: United States Government Work/flickr

I was a little confused last week when the FDA issued what was portrayed as a reassuring update on levels of arsenic in rice and rice products. After analyzing more than 1,300 rice-containing foods, the agency said, essentially, that the arsenic in rice won’t kill you, at least not today. The headline in The New York Times mirrored most of the media coverage: “No Immediate Risk Found In Arsenic Levels in Rice,” it said.

OK, but what about last year’s Consumer Reports investigation (which the FDA confirmed) that showed “worrisome levels” of arsenic in rice, notably brown rice, in common food products including “organic rice baby cereal, rice breakfast cereals, brown rice [and] white rice”? Consumer Reports noted that “arsenic not only is a potent human carcinogen but also can set up children for other health problems in later life.”

When I read the updated FDA materials, including an FAQ for consumers and a blog by FDA Commissioner Margaret Hamburg, who went on a fact-finding mission and visited with U.S. rice growers, it became clear that we should still be concerned about arsenic in our rice. The key point in this new flurry of agency news? “We still need to better understand long-term health risks,” Continue reading →

August 27, 2013 | 5:54 PM | Karen Weintraub

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.

2day929/flickr

In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said. Continue reading →

Alison Bass raises several excellent points in her post today about a recent Institute of Medicine report on deficiencies at the FDA when it comes to drug-safety oversight.

Basically, she writes, the IOM’s takeaway is that the FDA isn’t doing an adequate job of assessing the risks and benefits of drugs:

Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.

It’s troubling enough that the FDA may not be safeguarding the drug supply, Bass notes, but it’s particularly frustrating that the media isn’t paying attention:

Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?

More revelations about the problems with vaginal mesh implants, which we’ve written about here and here.

Bloomberg reports that Johnson & Johnson sold one early version of the vaginal mesh product before U.S. regulators approved it:

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Enlarge image

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

About CommonHealth

Massachusetts is the leading laboratory for health care reform in the nation, and a hub of medical innovation. From the lab to your doctor’s office, from the broad political stage to the numbers on your scale, we’d like CommonHealth to be your go-to source for news, conversation and smart analysis. Your hosts are Carey Goldberg, former Boston bureau chief of The New York Times, and Rachel Zimmerman, former health and medicine reporter for The Wall Street Journal.GET IN TOUCH

FOLLOW US

ABOUT THIS SITE

Massachusetts is the leading laboratory for health care reform in the nation, and a hub of medical innovation. From the lab to your doctor’s office, from the broad political stage to the numbers on your scale, we’d like CommonHealth to be your go-to source for news, conversation and smart analysis. Your hosts are Carey Goldberg, former Boston bureau chief of The New York Times, and Rachel Zimmerman, former health and medicine reporter for The Wall Street Journal.

A new study on the growing problem of peanut allergy made a big splash this week. It’s no cure for kids who have it, but it does show how many children may avoid it. And it promises to accelerate the search for the cause of this mysterious epidemic.